WO2021136969A1 - Dispositif d'implantation - Google Patents

Dispositif d'implantation Download PDF

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Publication number
WO2021136969A1
WO2021136969A1 PCT/IB2020/001095 IB2020001095W WO2021136969A1 WO 2021136969 A1 WO2021136969 A1 WO 2021136969A1 IB 2020001095 W IB2020001095 W IB 2020001095W WO 2021136969 A1 WO2021136969 A1 WO 2021136969A1
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WO
WIPO (PCT)
Prior art keywords
degrees
millimeters
longitudinal axis
portions
length
Prior art date
Application number
PCT/IB2020/001095
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English (en)
Inventor
Yoni MANOR
Original Assignee
Manor Yoni
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Application filed by Manor Yoni filed Critical Manor Yoni
Publication of WO2021136969A1 publication Critical patent/WO2021136969A1/fr

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Classifications

    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F9/00—Methods or devices for treatment of the eyes; Devices for putting-in contact lenses; Devices to correct squinting; Apparatus to guide the blind; Protective devices for the eyes, carried on the body or in the hand
    • A61F9/0008—Introducing ophthalmic products into the ocular cavity or retaining products therein
    • A61F9/0017—Introducing ophthalmic products into the ocular cavity or retaining products therein implantable in, or in contact with, the eye, e.g. ocular inserts
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2250/00—Special features of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof
    • A61F2250/0058—Additional features; Implant or prostheses properties not otherwise provided for
    • A61F2250/0067—Means for introducing or releasing pharmaceutical products into the body

Definitions

  • the field of invention relates to a device for use in the implantation of medical devices into tissue.
  • the field of invention relates to a device for use in the implantation of medical devices into tissue of the human eye.
  • a wide range of attempted solutions to this treatment challenge were and still are in development in order to provide a sustained release-based mechanism of active pharmaceutical ingredients (“APIs”).
  • Some of these solutions include inserts that are positioned in different compartments of the eye (e.g., within the tear canal, intraocularly within a chamber of the eye, or sub-conjunctival).
  • Proper and efficient placement of the devices is critical to the safety of the process and to the success of the treatment. The nature of the placement process also has commercial significance, as patients avoid unpleasant treatments.
  • Sub-conjunctival placement of an insert often includes a process of “carving a pocket” within tissue of the eye. This process will require forming a snip in the conjunctiva, separation of the conjunctive from underlying tissues, and later closing of the snip. Typically, this is done under local anesthesia, which is both stressful and inconvenient to the patient. Additionally, due to variability in this procedure, at times an insert may not be tightly tucked into place, possibly resulting in dislocation to an extent such that the insert forces its way out of the eye through the conjunctiva and the treatment is ceased.
  • IOL intra-ocular lens
  • Delivery systems in the form of intra-ocular lens (“IOL”) injectors are commercially available in different shapes and designs. However, all are characterized with a blunt tip fitted in size to a snip in the cornea, which must be made in advance with a dedicated tool. Such delivery devices are also designed to be used in a specific orientation with respect to the eye, for ergonomic and safety considerations.
  • Figure 1 shows a perspective view of an exemplary implantation device.
  • Figure 2 shows a side view of the exemplary implantation device shown in Figure 1.
  • Figure 3 shows a bottom view of the exemplary implantation device shown in Figure 1.
  • Figure 4 shows a front view of the exemplary implantation device shown in Figure 1.
  • Figure 5 shows a detailed bottom view of a tip of the exemplary implantation device shown in Figure 1.
  • Figure 6 shows a detailed front view of a portion of the front view shown in Figure 4.
  • Figure 7 shows a cross-sectional view of the exemplary implantation device shown in Figure 1, taken at the location labeled 7-7 in Figure 2.
  • Figure 8 shows a detailed view of a portion of the cross-sectional view shown in Figure 7.
  • an implantation device has a first end and a second end opposite the first end; the first end is configured to engage an IOL injector; and the second end includes a pointed tip configured to penetrate tissue of an eye and an insertion portion configured to pass therethrough an implantable device from the IOL injector for implantation in the eye.
  • a device in some embodiments, includes a body having a first end, a second end opposite the first end, a top side extending from the first end to the second end, and a bottom side opposite the top side, wherein the body comprises: a first portion having a hollow and substantially conical shape about a longitudinal axis, the first portion extending from the first end of the body to a transition intermediate the first and second ends of the body, and a second portion having a hollow and substantially cylindrical shape about the longitudinal axis, the second portion extending from the transition to the second end of the body, wherein the first portion and the second portion define a passage having a first inner diameter at the first end and a second inner diameter at the second end, wherein the first inner diameter is larger than the second inner diameter, wherein the first end is configured to engage an intra-ocular lens injector; wherein the second end includes a pointed tip configured to penetrate tissue of an eye, and wherein an insertion opening is formed in the bottom side of the body and extends from the second end of the body
  • the bevel angle is in a range of from 10 degrees to 14 degrees.
  • the pointed tip is angled with respect to the planar face at a lancet angle that is in a range of from 8 degrees to 12 degrees.
  • the first and second concave portions have a radius of curvature that is in a range of from 1 millimeter to 3 millimeters.
  • the pointed tip defines a tip angle that is in a range of from 60 degrees to 68 degrees.
  • the device is configured for use with an implantable device having an implantable device length, and wherein the insertion opening has a length along the longitudinal axis that is greater than the implantable device length by from 0.5 mm to 2 mm.
  • the second portion of the body and the first and second parallel portions define an arc angle that is in a range of from 90 degrees to 150 degrees.
  • the second portion of the body has an inner diameter that is in a range of from 1.5 mm to 3 mm.
  • the first end of the body has an inner diameter that is in a range of from 2 mm to 5 mm.
  • a length of the device along the longitudinal axis is in a range of from 7 mm to 20 mm.
  • the present disclosure describes an exemplary embodiment of an add-on insertion device that is configured to couple to standard commercially available IOL delivery systems. It will be apparent to those of skill in the art that the general principles embodied in the exemplary device may also be embodied in other devices.
  • Figure 1-8 show various views of an exemplary implantation device 100 (for brevity, “device 100”). Certain ones of Figures 1-8 include dimensions of certain aspects of the device 100, with lengths shown as measured in millimeters and angles shown as measured in degrees. However, it will be apparent to those of skill in the art that the specific dimensions shown in Figures 1-8 are only exemplary and that other dimensions are possible without departing from the general concepts embodied by the exemplary embodiments, including, but not limited to, those described herein.
  • Figure 1 shows a perspective view of the device 100.
  • Figure 2 shows a side view of the device 100.
  • Figure 3 shows a bottom view of the device 100.
  • Figure 4 shows a front view of the device 100.
  • Figure 5 shows a detailed bottom view of a tip of the device 100.
  • Figure 6 shows a detailed front view of a portion of the device 100 as shown in Figure 4.
  • Figure 7 shows a cross-sectional view of the device 100 taken at the location labeled 7-7 in Figure 2.
  • Figure 8 shows a detailed view of a portion of the cross-sectional view shown in Figure 7.
  • the device 100 has a body including a fitting section 110 (i.e., a first portion) and a protrusion 120 (i.e., a second portion) that meet at an arcuate transition 130.
  • the device 100 is oriented about a longitudinal axis A.
  • the fitting section 110 includes a first end 112 that is configured for coupling to an intraocular lens (“IOL”) cartridge and a second end 114 that is opposite the first end 112 and is coincident with the transition 130.
  • IOL intraocular lens
  • the fitting section 110 has the general shape of a hollow right circular cone about the longitudinal axis A having portions removed therefrom as will be described hereinafter.
  • the protrusion 120 includes a first end 122 that is coincident with the transition 130 and a second end 124 opposite the first end 122.
  • the protrusion 120 has a hollow and substantially cylindrical shape about the longitudinal axis A having portions removed therefrom as will be described hereinafter.
  • the hollow interior of the fitting section 110 and the hollow interior of the protrusion 120 cooperate to define a passage.
  • the device 100 is formed from a single piece of material (e.g., is a monolithic item). In some embodiments, the device 100 is formed from a material that is biocompatible and has sufficient stiffness to hold a sharp edge. In some embodiments, the material is an alloy. In some embodiments, the material is a steel alloy. In some embodiments, the material is a stainless steel alloy. In some embodiments, the material is 304L stainless steel. In some embodiments, the material is a polymer. In some embodiments, the polymer is polymethyl methacrylate (“PMMA”).
  • PMMA polymethyl methacrylate
  • the device 100 includes a top 102 and a bottom 104.
  • the device 100 includes a left side 106 and a right side 108 (e.g., a first lateral side and a second lateral side).
  • the terms “top,” “bottom,” “left,” and “right” are used herein to provide a frame of reference for description of the various elements of the device 100, and that, when in use, the device 100 may be positioned in any orientation with respect to a real-world coordinate system, and need not be oriented such that the top 102, the bottom 104, the left side 106, or the right side 108 are positioned in any particular direction.
  • the bottom 104 of the device 100 includes an insertion portion 140, which includes certain surfaces that will be described hereinafter.
  • the insertion portion 140 defines an insertion opening.
  • the insertion portion 140 is symmetric (i.e., the two sides of the insertion portion 140 are mirror images of one another to opposite sides of the longitudinal axis A).
  • the insertion portion 140 is not symmetric (i.e., is different to the “left” side of the device than to the “right” side of the device).
  • the insertion portion 140 includes a planar face 142 formed in the fitting section 110.
  • the planar face 142 is angled with respect to the longitudinal axis A. In some embodiments, the planar face 142 is angled with respect to the longitudinal axis A by an angle that is from 5 degrees to 45 degrees. In some embodiments, the planar face 142 provides for a smooth progression of the device 100 along tissues of the eye.
  • the insertion portion 140 includes first and second convex portions 144 extending from the planar face 142 toward the longitudinal axis A and away from the first end 112 of the fitting section 110.
  • the convex portions 144 are convex with respect to the longitudinal axis A , as viewed from the side as shown in Figure 2, with a first one of the convex portions 144 being located to the left side 106 and a second one of the convex portions 144 being located to the right side 108 of the device 100.
  • the size of the first and second convex portions 144 (e.g., the radius of curvature of the first and second convex portions) is determined as the sizing necessary to provide a smooth transition between the planar face 142 and the first and second concave portions 146.
  • the radius of curvature of the first and second convex portions 144 is from 0 (e.g., the first and second convex portions 144 are missing and the planar face 142 transitions directly into the first and second concave portions 146) to 3.5 millimeters.
  • the insertion portion 140 includes first and second concave portions 146, which extend from respective ones of the first and second convex portions 144 in a direction toward and past the longitudinal axis A , as viewed from the side as shown in Figure 2, and away from the first end 112 of the fitting section 110.
  • the first and second concave portions 146 are concave with respect to the bottom 104 of the device 100.
  • the radius of curvature R1 of the first and second concave portions 146 is from 1 millimeter to 3 millimeters.
  • the radius of curvature R1 of the first and second concave portions 146 is from 1 millimeter to 2.5 millimeters. In some embodiments, the radius of curvature R1 of the first and second concave portions 146 is from 1 millimeter to 2 millimeters. In some embodiments, the radius of curvature R1 of the first and second concave portions 146 is from 1 millimeter to 1.5 millimeters. In some embodiments, the radius of curvature R1 of the first and second concave portions 146 is from 1.5 millimeters to 3 millimeters. In some embodiments, the radius of curvature R1 of the first and second concave portions 146 is from 1.5 millimeters to 2.5 millimeters.
  • the radius of curvature R1 of the first and second concave portions 146 is from 1.5 millimeters to 2 millimeters. In some embodiments, the radius of curvature R1 of the first and second concave portions 146 is from 2 millimeters to 3 millimeters. In some embodiments, the radius of curvature R1 of the first and second concave portions 146 is from 2 millimeters to 2.5 millimeters. In some embodiments, the radius of curvature R1 of the first and second concave portions 146 is from 2.5 millimeter to 3 millimeters.
  • the insertion portion 140 includes first and second parallel portions 148, which extend from respective ones of the first and second concave portions 146 in a direction away from the first end 112 of the fitting section 110 and parallel to the longitudinal axis A , as viewed from the side as shown in Figure 2.
  • the first and second parallel portions 148 are generally parallel to the longitudinal axis A (e.g., angled with respect to the longitudinal axis A by no more than 10 degrees)
  • the first and second parallel portions extend across the transition 130 from the fitting section 110 to the protrusion 120.
  • the insertion portion 140 includes first and second beveled portions 150, which extend from respective ones of the first and second parallel portions 148 in a direction away from the first end 112 of the fitting section 110 and away from the longitudinal axis A , as viewed from the side as shown in Figure 2.
  • the first and second beveled portions 150 are concave with respect to the longitudinal axis 4
  • the first and second beveled portions 150 meet at a tip 152.
  • the tip 152 is aligned with the longitudinal axis A when the device 100 is viewed from the bottom, i.e., the tip 152 is centered with respect to the left side 106 and the right side 108. In some embodiments, the tip is 152 is asymmetrical (e.g., is not centered with respect to the left side 106 and the right side 108).
  • the first and second beveled portions 150 meet at a tip angle b.
  • the tip angle b is 64.8 degrees.
  • the tip angle b is between 60 and 70 degrees. In some embodiments, the tip angle b is between 60 and 68 degrees.
  • the tip angle b is between 60 and 66 degrees. In some embodiments, the tip angle b is between 60 and 64 degrees. In some embodiments, the tip angle b is between 60 and 62 degrees. In some embodiments, the tip angle b is between 62 and 70 degrees. In some embodiments, the tip angle b is between 62 and 68 degrees. In some embodiments, the tip angle b is between 62 and 66 degrees. In some embodiments, the tip angle b is between 62 and 64 degrees. In some embodiments, the tip angle b is between 64 and 70 degrees. In some embodiments, the tip angle b is between 64 and 68 degrees. In some embodiments, the tip angle b is between 64 and 66 degrees.
  • the tip angle b is between 66 and 70 degrees. In some embodiments, the tip angle b is between 66 and 68 degrees. In some embodiments, the tip angle b is between 68 and 70 degrees. In some embodiments, the tip angle b is between 64.5 and 65.5 degrees.
  • the fitting section 110 has an outside diameter OD1 at the first end 112 thereof.
  • the outside diameter OD1 varies based on the size (e.g., diameter) of an implantable device to be implanted through use of the device 100.
  • the outside diameter OD1 is between 2.0 mm and 5.0 mm.
  • the outside diameter OD1 is between 2.0 mm and 4.5 mm.
  • the outside diameter OD1 is between 2.0 mm and 4.0 mm.
  • the outside diameter OD1 is between 2.0 mm and 3.5 mm.
  • the outside diameter OD1 is between 2.0 mm and 3.0 mm.
  • the outside diameter OD1 is between 2.0 mm and 2.5 mm. In some embodiments, the outside diameter OD1 is between 2.5 mm and 5.0 mm. In some embodiments, the outside diameter OD1 is between 2.5 mm and 4.5 mm. In some embodiments, the outside diameter OD1 is between 2.5 mm and 4.0 mm. In some embodiments, the outside diameter OD1 is between 2.5 mm and 3.5 mm. In some embodiments, the outside diameter OD1 is between 2.5 mm and 3.0 mm. In some embodiments, the outside diameter OD1 is between 3.0 mm and 5.0 mm. In some embodiments, the outside diameter OD1 is between 3.0 mm and 4.5 mm.
  • the outside diameter OD1 is between 3.0 mm and 4.0 mm. In some embodiments, the outside diameter OD1 is between 3.0 mm and 3.5 mm. In some embodiments, the outside diameter OD1 is between 3.5 mm and 5.0 mm. In some embodiments, the outside diameter OD1 is between 3.5 mm and 4.5 mm. In some embodiments, the outside diameter OD1 is between 3.5 mm and 4.0 mm. In some embodiments, the outside diameter OD1 is between 4.0 mm and 5.0 mm. In some embodiments, the outside diameter OD1 is between 4.0 mm and 4.5 mm. In some embodiments, the outside diameter OD1 is between 4.5 mm and 5.0 mm.
  • the outside diameter OD1 is between 3.0 mm and 3.8 mm. In some embodiments, the outside diameter OD1 is between 3.1 mm and 3.7 mm. In some embodiments, the outside diameter OD1 is between 3.2 mm and 3.6 mm. In some embodiments, the outside diameter OD1 is between 3.3 mm and 3.5 mm. In some embodiments, the outside diameter OD1 is approximately 3.4 millimeters. In some embodiments, the outside diameter OD1 is 3.4 millimeters.
  • the fitting section 110 has a hollow and substantially conical shape including an inside diameter ID at the first end 112 thereof.
  • the inside diameter ID coupled with the conical shape of the fitting section 110, is configured to provide for a press fit with an IOL injector to which the device 100 is to be coupled.
  • the inside diameter ID may depend on the size of an implantable device to be received at the first end 112 and implanted through use of the device 100.
  • the inside diameter ID is from 1.8 mm to 4.8 mm.
  • the inside diameter ID is from 1.8 mm to 4.3 mm.
  • the inside diameter ID is from 1.8 mm to 3.8 mm.
  • the inside diameter ID is from 1.8 mm to 3.3 mm. In some embodiments, the inside diameter ID is from 1.8 mm to 2.8 mm. In some embodiments, the inside diameter ID is from 1.8 mm to 2.3 mm. In some embodiments, the inside diameter ID is from 2.3 mm to 4.8 mm. In some embodiments, the inside diameter ID is from 2.3 mm to 4.3 mm. In some embodiments, the inside diameter ID is from 2.3 mm to 3.8 mm. In some embodiments, the inside diameter ID is from 2.3 mm to 3.3 mm. In some embodiments, the inside diameter ID is from 2.3 mm to 2.8 mm. In some embodiments, the inside diameter ID is from 2.8 mm to 4.8 mm.
  • the inside diameter ID is from 2.8 mm to 4.3 mm. In some embodiments, the inside diameter ID is from 2.8 mm to 3.8 mm. In some embodiments, the inside diameter ID is from 2.8 mm to 3.3 mm. In some embodiments, the inside diameter ID is from 3.3 mm to 4.8 mm. In some embodiments, the inside diameter ID is from 3.3 mm to 4.3 mm. In some embodiments, the inside diameter ID is from 3.3 mm to 3.8 mm. In some embodiments, the inside diameter ID is from 3.8 mm to 4.8 mm. In some embodiments, the inside diameter ID is from 3.8 mm to 4.3 mm. In some embodiments, the inside diameter ID is from 4.3 mm to 4.8 mm.
  • the inside diameter ID is from 2.8 mm to 3.4 mm. In some embodiments, the inside diameter ID is from 2.9 mm to 3.3 mm. In some embodiments, the inside diameter ID is from 3.0 mm to 3.2 mm. In some embodiments, the inside diameter ID is approximately 3.1 millimeters. In some embodiments, the inside diameter ID is 3.1 millimeters.
  • the fitting section 110 has a wall thickness WT at the first end thereof.
  • the wall thickness WT is constant throughout the device 100.
  • the wall thickness WT varies within the device 100.
  • the wall thickness WT is from 0.08 mm to 0.2 mm.
  • the wall thickness WT is from 0.08 mm to 0.17 mm.
  • the wall thickness WT is from 0.08 mm to 0.14 mm.
  • the wall thickness WT is from 0.08 mm to 0.11 mm.
  • the wall thickness WT is from 0.11 mm to 0.2 mm.
  • the wall thickness WT is from 0.11 mm to 0.17 mm. In some embodiments, the wall thickness WT is from 0.11 mm to 0.14 mm. In some embodiments, the wall thickness WT is from 0.14 mm to 0.2 mm. In some embodiments, the wall thickness WT is from 0.14 mm to 0.17 mm. In some embodiments, the wall thickness WT is from 0.17 mm to 0.2 mm. In some embodiments, the wall thickness WT is from 0.13 mm to 0.17 mm. In some embodiments, the wall thickness WT is from 0.14 mm to 0.16 mm. In some embodiments, the wall thickness WT is about 0.15 mm. In some embodiments, the wall thickness WT is 0.15 mm.
  • the device 100 has an overall length LT as measured parallel to the longitudinal axis A and from the first end 112 of the fitting section 110 to the tip 152.
  • the overall length LT is from 7.0 mm to 20.0 mm.
  • the overall length LT is from 7.0 mm to 16.75 mm.
  • the overall length LT is from 7.0 mm to 13.5 mm.
  • the overall length LT is from 7.0 mm to 10.25 mm.
  • the overall length LT is from 10.25 mm to 20.0 mm.
  • the overall length LT is from 10.25 mm to 16.75 mm.
  • the overall length LT is from 10.25 mm to 13.5 mm. In some embodiments, the overall length LT is from 13.5 mm to 20.0 mm. In some embodiments, the overall length LT is from 13.5 mm to 16.75 mm. In some embodiments, the overall length LT is from 16.75 mm to 20.0 mm. In some embodiments, the overall length LT is from 14 mm to 20 mm. In some embodiments, the overall length LT is from 15 mm to 19 mm. In some embodiments, the overall length LT is from 16 mm to 18 mm. In some embodiments, the overall length LT is about 17 mm. In some embodiments, the overall length LT is between 17 mm and 17.3 mm. In some embodiments, the overall length LT is 17.16 mm.
  • the device has a length L2 as measured parallel to the longitudinal axis A and from the transition between the concave portions 146 and the parallel portions 148 to the tip 152.
  • the length L2 is determined by the length along the insertion axis of an insert for which the device 100 is designated for use. In some embodiments, the length L2 is equal to the length along the insertion axis of an insert for which the device 100 is designated for use. In some embodiments, the length L2 is approximately equal to the length along the insertion axis of an insert for which the device 100 is designated for use.
  • the length L2 is in a range between (1) equal to the length along the insertion axis of an insert for which the device 100 is designated for use, and (2) 0.1 millimeter greater than the length along the insertion axis of an insert for which the device 100 is designated for use.
  • the length L2 is from 2 mm to 6 mm. In some embodiments, the length L2 is from 2 mm to 5 mm. In some embodiments, the length L2 is from 2 mm to 4 mm. In some embodiments, the length L2 is from 2 mm to 3 mm. In some embodiments, the length L2 is from 3 mm to 6 mm. In some embodiments, the length L2 is from 3 mm to 5 mm.
  • the length L2 is from 3 mm to 4 mm. In some embodiments, the length L2 is from 4 mm to 6 mm. In some embodiments, the length L2 is from 4 mm to 5 mm. In some embodiments, the length L2 is from 5 mm to 6 mm. In some embodiments, the length L2 is from 5.1 mm to 5.5 mm. In some embodiments, the length L2 is from 5.2 mm to 5.4 mm. In some embodiments, the length L2 is about 5.3 mm. In some embodiments, the length L2 is 5.3 millimeters.
  • the device 100 has a length LI as measured parallel to the longitudinal axis A and from the first end 112 of the fitting section 110 to the transition between the concave portions 146 and the parallel portions 148.
  • the length LI is determined as a function of the overall length LT of the device 100 and the length L2.
  • the length LI is the overall length LT minus the length L2.
  • the length LI is 11.9 mm.
  • the device has a length L3 as measured parallel to the longitudinal axis A and from the first end 112 of the conical portion to the transition between the planar face 142 and the convex portions 144.
  • the length L3 is selected in order to ensure that an insert that is being inserted through use of the device 100 is suitably installed.
  • the length L3 is at least 0.1 millimeter greater than the length of the “beak” of an insert to be inserted.
  • the length L3 is in a range from 1 millimeter to 14 millimeters. In some embodiments, the length L3 is in a range from 1 millimeter to 10.75 millimeters.
  • the length L3 is in a range from 1 millimeter to 7.5 millimeters. In some embodiments, the length L3 is in a range from 1 millimeter to 4.25 millimeters. In some embodiments, the length L3 is in a range from 4.25 millimeter to 14 millimeters. In some embodiments, the length L3 is in a range from 4.25 millimeter to 10.75 millimeters. In some embodiments, the length L3 is in a range from 4.25 millimeter to 7.5 millimeters. In some embodiments, the length L3 is in a range from 7.5 millimeter to 14 millimeters. In some embodiments, the length L3 is in a range from 7.5 millimeter to 10.75 millimeters.
  • the length L3 is in a range from 10.75 millimeter to 14 millimeters. In some embodiments, the length L3 is in a range from 9 millimeters to 10 millimeters. In some embodiments, the length L3 is in a range from 9.2 millimeters to 9.6 millimeters. In some embodiments, the length L3 is about 9.5 millimeters. In some embodiments, the length L3 is about 9.4 millimeters. In some embodiments, the length L3 is 9.4 millimeters.
  • the device has a length L4 as measured parallel to the longitudinal axis A and from the transition between the planar face 142 and the convex portions 144 to the tip 152.
  • the length L4 is determined as a function of the overall length LT of the device 100 and the length L3.
  • the length L4 is the overall length LT minus the length L3.
  • the length L4 is 7.75 millimeters.
  • the fitting section 110 defines an aperture angle a.
  • the aperture angle a depends on an external device (e.g., an IOL inserter) to which the device 100 is configured to connect.
  • the aperture angle a is from 3.2 degrees to 8.5 degrees.
  • the aperture angle a is from 3.2 degrees to 7.2 degrees.
  • the aperture angle a is from 3.2 degrees to 5.9 degrees.
  • the aperture angle a is from 3.2 degrees to 4.5 degrees.
  • the aperture angle a is from 4.5 degrees to 8.5 degrees.
  • the aperture angle a is from 4.5 degrees to 7.2 degrees.
  • the aperture angle a is from 4.5 degrees to 5.9 degrees. In some embodiments, the aperture angle a is from 5.9 degrees to 8.5 degrees. In some embodiments, the aperture angle a is from 5.9 degrees to 7.2 degrees. In some embodiments, the aperture angle a is from 7.2 degrees to 8.5 degrees. In some embodiments, the aperture angle a is from 5.75 degrees to 6.75 degrees. In some embodiments, the aperture angle a is from 6 degrees to 6.5 degrees. In some embodiments, the aperture angle a is about 6.25 degrees. In some embodiments, the aperture angle a is 6.24 degrees. [0051] Referring now to Figure 3, the first and second parallel portions 148 define a width W1 when viewed as shown in Figure 3.
  • the width W1 may vary depending on the size of an insert to be inserted through use of the device 100. In some embodiments, the width W1 is sufficiently wide so as to shelter a full width (e.g., diameter) of an insert to be inserted through the use of the device 100 from contact with the conjunctiva when the insert unfolds. In some embodiments, the width W1 is 1.5 to 2.5 millimeters. In some embodiments, the width W1 is 1.5 to 2.25 millimeters. In some embodiments, the width W1 is 1.5 to 2 millimeters. In some embodiments, the width W1 is 1.5 to 1.75 millimeters. In some embodiments, the width W1 is 1.75 to 2.5 millimeters. In some embodiments, the width W1 is
  • the width W1 is 1.75 to 2.25 millimeters. In some embodiments, the width W1 is 1.75 to 2 millimeters. In some embodiments, the width W1 is 2 to 2.5 millimeters. In some embodiments, the width W1 is 2 to 2.25 millimeters. In some embodiments, the width W1 is 2.25 to 2.5 millimeters. In some embodiments, the width W1 is between 1.7 and 2.1 millimeters. In some embodiments, the width W1 is between 1.8 and 2.0 millimeters. In some embodiments, the width W1 is about 1.9 millimeters. In some embodiments, the width W1 is 1.91 millimeters.
  • the protrusion 120 defines an inner diameter IDl.
  • the inner diameter IDl may vary depending on the size of an insert to be inserted through use of the device 100.
  • the inner diameter IDl is 1.5 to 3.0 millimeters.
  • the inner diameter IDl is 1.5 to 2.75 millimeters.
  • the inner diameter IDl is 1.5 to 2.5 millimeters.
  • the inner diameter IDl is 1.5 to 2.25 millimeters.
  • the inner diameter IDl is 1.5 to 2 millimeters.
  • the inner diameter IDl is 1.5 to 1.75 millimeters.
  • the inner diameter IDl is 1.75 to 3.0 millimeters.
  • the inner diameter IDl is 1.75 to 2.75 millimeters. In some embodiments, the inner diameter IDl is 1.75 to 2.5 millimeters. In some embodiments, the inner diameter IDl is 1.75 to 2.25 millimeters. In some embodiments, the inner diameter IDl is 1.75 to 2 millimeters. In some embodiments, the inner diameter IDl is 2 to 3 millimeters. In some embodiments, the inner diameter IDl is 2 to
  • the inner diameter IDl is 2 to 2.5 millimeters. In some embodiments, the inner diameter IDl is 2 to 2.25 millimeters. In some embodiments, the inner diameter IDl is 2.25 to 3 millimeters. In some embodiments, the inner diameter IDl is 2.25 to 2.75 millimeters. In some embodiments, the inner diameter IDl is 2.25 to 2.5 millimeters. In some embodiments, the inner diameter IDl is 2.5 to 3 millimeters. In some embodiments, the inner diameter IDl is 2.5 to 2.75 millimeters. In some embodiments, the inner diameter IDl is 2.75 to 3 millimeters. In some embodiments, the inner diameter IDl is 1.5 to 1.9 millimeters. In some embodiments, the inner diameter IDl is 1.6 to 1.8 millimeters. In some embodiments, the inner diameter IDl is about 1.7 millimeters. In some embodiments, the inner diameter IDl is 1.70 millimeters.
  • the protrusion 120 defines an arc angle g representing the portion of a full (i.e., circular) cylinder spanned by the protrusion 120.
  • the arc angle g may vary depending on the size of an insert to be inserted through use of the device 100.
  • the arc angle g is between 90 degrees and 150 degrees.
  • the arc angle g is between 90 degrees and 135 degrees.
  • the arc angle g is between 90 degrees and 120 degrees.
  • the arc angle g is between 90 degrees and 105 degrees.
  • the arc angle g is between 105 degrees and 150 degrees.
  • the arc angle g is between 105 degrees and 135 degrees. In some embodiments, the arc angle g is between 105 degrees and 120 degrees. In some embodiments, the arc angle g is between 120 degrees and 150 degrees. In some embodiments, the arc angle g is between 120 degrees and 135 degrees. In some embodiments, the arc angle g is between 135 degrees and 150 degrees. In some embodiments, the arc angle g is between 100 degrees and 120 degrees. In some embodiments, the arc angle g is between 105 degrees and 115 degrees. In some embodiments, the arc angle g is about 110 degrees. In some embodiments, the arc angle g is 110 degrees.
  • the protrusion 120 defines a height H as measured perpendicularly to the longitudinal axis A from the first and second parallel portions 148 to the top 102.
  • the height H is a function of the width W 1 shown in Figure 3 and the angle g shown in Figure 8.
  • the width W 1 may vary depending on the size of an insert to be inserted through use of the device 100.
  • the height H may also vary depending on the size of an insert to be inserted through use of the device 100.
  • the height H is from 0.1 millimeters to 1.5 millimeters.
  • the height H is from 0.1 millimeters to 1.15 millimeters. In some embodiments, the height H is from 0.1 millimeters to 0.8 millimeters. In some embodiments, the height H is from 0.1 millimeters to 0.45 millimeters. In some embodiments, the height H is from 0.45 millimeters to 1.5 millimeters. In some embodiments, the height H is from 0.45 millimeters to 1.15 millimeters. In some embodiments, the height H is from 0.45 millimeters to 0.8 millimeters. In some embodiments, the height H is from 0.8 millimeters to 1.5 millimeters. In some embodiments, the height H is from 0.8 millimeters to 1.15 millimeters.
  • the height H is from 1.15 millimeters to 1.5 millimeters. In some embodiments, the height H is from 0.5 millimeters to 0.9 millimeters. In some embodiments, the height H is from 0.6 millimeters to 0.8 millimeters. In some embodiments, the height H is about 0.7 millimeters. In some embodiments, the height H is 0.7 millimeters.
  • the first and second beveled portions 150 define a bevel angle d with respect to the longitudinal axis A when viewed from the side as shown in Figure 2.
  • the bevel angle d is the base grind angle for the needle tip of the device 100, i.e., is the base angle from which the grinding of the first and second beveled portions 150 are formed.
  • the portion of the material of the device 100 that will form the first and second beveled portions 150 is first rough processed to the bevel angle d, and then is finely processed to form the edges of the first and second beveled portions 150.
  • the bevel angle d is between 10 degrees and 14 degrees.
  • the bevel angle d is between 11 degrees and 13 degrees. In some embodiments, the bevel angle d is between 11.5 and 12.5 degrees. In some embodiments, the bevel angle d is about 12 degrees. In some embodiments, the bevel angle d is 12 degrees. In some embodiments, the planar face 142 is also aligned with the angle d (i.e., is angled with respect to the longitudinal axis A by the angle d). [0056] Continuing to refer to Figure 2, the first and second beveled portions 150 define a thickness T, as viewed from the side as shown in Figure 2. In some embodiments, the thickness T varies along an insertion direction. In some embodiments, the thickness T is sufficiently thin so as to provide for smooth insertion into the eye.
  • the thickness T defines the amount of material removed as measured perpendicularly to the plane defined by the angle d that defines the first and second beveled portions 150. In some embodiments, the thickness T is from 0.08 to 0.2 millimeters. In some embodiments, the thickness T is from 0.08 to 0.17 millimeters. In some embodiments, the thickness T is from 0.08 to 0.14 millimeters. In some embodiments, the thickness T is from 0.08 to 0.11 millimeters. In some embodiments, the thickness T is from 0.11 to 0.2 millimeters. In some embodiments, the thickness T is from 0.11 to 0.17 millimeters. In some embodiments, the thickness T is from 0.11 to 0.14 millimeters.
  • the thickness T is from 0.14 to 0.2 millimeters. In some embodiments, the thickness T is from 0.14 to 0.17 millimeters. In some embodiments, the thickness T is from 0.17 to 0.2 millimeters. In some embodiments, the thickness T is from 0.13 to 0.17 millimeters. In some embodiments, the thickness T is from 0.14 to 0.16 millimeters. In some embodiments, the thickness T is about 0.15 millimeters. In some embodiments, the thickness T is 0.15 millimeters.
  • the tip 152 forms a lancet angle e with respect to the bevel angle d defining the first and second beveled portions 150.
  • the lancet angle e is configured to provide for smooth insertion of the tip 152 into the tissue of the eye.
  • the lancet angle e is between 8 degrees and 12 degrees.
  • the lancet angle e is between 9 degrees and 11 degrees.
  • the lancet angle e is between 9.5 degrees and 10.5 degrees.
  • the lancet angle e is about 10 degrees. In some embodiments, the lancet angle e is 10 degrees.
  • the tip 152 and the first and second beveled portions 150 form a sharp tip that is suitable for penetrating the conjunctiva of a human eye.
  • the top 102 of the device 100 is suitably smooth and polished so as to slide within the eye and below the conjunctiva once the tip 152 has penetrated into the eye.
  • the bottom 104 of the device 100 is suitably polished so as to avoid contact with the sclera of the eye after the tip 152 has penetrated into the eye.
  • at least one portion of the outer surface of the device 100 e.g., the surface facing away from the longitudinal axis A
  • at least one portion of the inner surface of the device 100 is smooth to a level of Ra 3.2 pm or greater.
  • the insertion portion 140 can be referred to as having a “duck bill” shape having a profile that is sufficiently sized so as to allow an insert to pass through the device 100 (e.g., into the device through the first end 112 of the fitting section 110 and out of the device through the insertion portion 140) and be inserted into the eye with minimal contact with the conjunctiva.
  • the length of the insertion portion 140 (e.g., as measured along the longitudinal axis A) may vary depending on the length of an insert that is to be inserted by use of the device 100. In some embodiments, the length of the insertion portion 140 is longer than a length of an insert by at least 0.5 mm.
  • the length of the insertion portion 140 is longer than a length of an insert by no more than 2.0 mm. In some embodiments, the length of the insertion portion 140 is longer than a length of an insert by an amount between 0.5 mm and 2.0 mm. In some embodiments, the width of the insertion portion 140 (e.g., as measured perpendicular to the longitudinal axis A in a viewing plane as shown in Figure 4) may vary depending on the width of an insert that is to be inserted by use of the device 100. In some embodiments, the width of the insertion portion 140 may vary depending on an unfolded width of an insert that is to be inserted into the eye while folded. In some embodiments, the width of the insertion portion 140 is at least 60% of the unfolded width of the insert.
  • the device 100 is used as follows.
  • a user couples the device 100 to an IOL inserter (or other suitable device) by engaging the fitting section 110 to the IOL inserter.
  • the device 100 is inserted into the eye by penetrating the conjunctiva of an eye of a patient with the tip 152 and sliding the tip 152 to a desired insertion location.
  • smoothness of the exterior surfaces of the device 100 allows the device to be moved easily to the insertion location with minimal friction.
  • the user deploys an insert (e.g., an insert providing for delayed release of an API) through the device 100, exiting the device 100 via the insertion portion 140, in a manner consistent with standard operation of the IOL inserter.
  • an insert e.g., an insert providing for delayed release of an API
  • the user withdraws the device 100 from the eye.
  • the device 100 is single-use and is disposed of following withdrawal from the eye.
  • the device 100 is reusable and can be used for subsequent insertion processes after suitable sterilization.
  • the foregoing exemplary method presents an improvement over prior techniques for insertion of such inserts, as only one insertion is required, as opposed to techniques in which a practitioner first forms a pocket with a scalpel, and subsequently inserts the IOL inserter into the pocket to deploy the insert.
  • Such a one-insertion process therefore presents a one-step process for implantation of an IOL insert, as opposed to the two-step process required by prior devices. Consequently, the exemplary embodiments will simplify and shorten the placement procedure, thereby increasing patients’ willingness to undergo the procedure and in parallel increase its success rate.

Abstract

La présente invention concerne un dispositif ayant une première extrémité, une seconde extrémité et un côté inférieur ; le dispositif comprenant une partie conique creuse au niveau de la première extrémité et une partie cylindrique creuse au niveau de la seconde extrémité ; la première extrémité étant conçue pour venir en prise avec un injecteur de lentille intraoculaire ; la seconde extrémité comprenant une pointe pointue conçue pour pénétrer dans un tissu d'un œil. Une ouverture est formée dans le côté inférieur du dispositif, s'étend de la seconde extrémité vers la première extrémité, est conçue pour passer au travers d'un dispositif implantable reçu au niveau de la première extrémité pour une implantation dans l'œil, et est délimitée par des première et seconde parties biseautées s'étendant à partir de la pointe pointue vers la première extrémité, des première et seconde parties parallèles s'étendant à partir des parties biseautées, des première et seconde parties concaves s'étendant à partir des parties parallèles, et une face plane s'étendant à partir des parties concaves.
PCT/IB2020/001095 2019-12-31 2020-12-30 Dispositif d'implantation WO2021136969A1 (fr)

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